![](https://investorshub.advfn.com/uicon/564105.png?cb=1547105359)
Wednesday, January 29, 2020 9:40:12 AM
From the early November Short Form Prospectus:
"While the Company is assessing the availability of sufficient financing, it has taken temporary measures to reduce
its cash burn over its historical rates, including a significant reduction in its rate of development, sourcing more cost-
effective resources and reducing its general and administrative overhead where possible. Having regard to the foregoing and contingent on the availability of sufficient financing allowing the Company to advance the development of its robotic surgical system in a timely and cost-effective manner as well as normalizing supplier relationships and resumption of normal course operations, and the absence of unanticipated product development and verification difficulties, the Company estimates that it will need to raise, in addition to the proceeds from the Maximum Offering, approximately US $70.0 million in order to be in a position to file its 510(k) application with the FDA in 2021."
This Prospectus was published with the proposed (subsequently cancelled) offering for Min $15M and max $25M. Therefore the estimate was $25M + $70M = $95M to get to 510K submission. This presumably includes instrument improvements, software development, electrical and biocomp testing, IDE application, rebranding (was still in the milestones before 510K), IRB approvals, and human confirmatory studies for the 510K. Interestingly, they also listed ongoing software development AFTER the 510K submission.
Message in reply to:
When does the clinical testing start that is needed for FDA submission ? Also how much will that cost ? Do tell
Should be sued for keeping material info away from shareholders
** All you have to do is go back into Q1 or Q2 2019 timelines and look at the projected cost estimates for Milestones #9 to the end to give you an idea of what is still needed, $$$-wise
FEATURED POET Wins "Best Optical AI Solution" in 2024 AI Breakthrough Awards Program • Jun 26, 2024 10:09 AM
HealthLynked Promotes Bill Crupi to Chief Operating Officer • HLYK • Jun 26, 2024 8:00 AM
Bantec's Howco Short Term Department of Defense Contract Wins Will Exceed $1,100,000 for the current Quarter • BANT • Jun 25, 2024 10:00 AM
ECGI Holdings Targets $9.7 Billion Equestrian Apparel Market with Allon Brand Launch • ECGI • Jun 25, 2024 8:36 AM
Avant Technologies Addresses Progress on AI Supercomputer-Driven Data Centers • AVAI • Jun 25, 2024 8:00 AM
Green Leaf Innovations, Inc. Expands International Presence with New Partnership in Dubai • GRLF • Jun 24, 2024 8:30 AM